Executive Summary
On January 1, 2018, healthcare reform laws became effective in Ukraine. The reform is the first comprehensive change to the country’s health system since independence in 1991. This program was launched on the primary medical care level starting from July 1, 2018 and will be fully implemented on all levels of medical care beginning January 1, 2020. Costs of medical services are covered by payments made to healthcare institutions by the newly created National Health Service (NHS). As of the beginning of 2019, 97% of healthcare facilities have switched to the new financing model; around 20% of these were private institutions. The NHS paid $128.6 million to healthcare facilities in 2018, and $49.6 million in January 2019.
Under the new system, patients can choose their own doctor and are now in the process of signing declarations that will be included in the electronic health database. As of April 2019, 26 million people, equal to nearly 60% of the population, had signed declarations with family physicians, therapists or pediatricians.
A list of medical services, medical devices, and pharmaceuticals to be provided to patients free of charge will be adopted each year as part of the state budget. The costs of emergency, primary, secondary, tertiary, and palliative care, including services and medications, will be fully covered by the state under the healthcare guarantees program. At least 5% of Gross Domestic Product (GDP) will be allocated each year for the healthcare guarantees program.
There is no accurate statistical data on the size of the Ukrainian medical equipment market. According to the BMI (Business Monitor International) forecast, the Ukrainian medical device market will record double-digit growth, in local currency terms, over the 2018-2020 period.
In 2018, the Ukrainian medical device market was worth $532.6 million, and it is projected to reach $524.7 million in 2019 (Source: National Statistics/BMI). Multiple factors are driving the growth: new healthcare legislation, which changes the way healthcare is financed; the comprehensive hospital sector; the ongoing World Bank project approved in March 2015; and Ministry of Health plans to expand the network of clinics in rural areas.
In 2018, imports accounted for 90% of medical device sales in Ukraine. Major trade partners in this segment include:
- United States (U.S.) - particularly strong in the supply of orthopedics, prosthetics, and diagnostic imaging equipment
- China - strong in the supply of consumables and patient aids
- Germany – the leader in dental imports
- Japan – strong in imaging equipment imports
The U.S. share was about 10% of total imports, and almost 2% of orthopedics and prosthetics imports.
The Ukrainian market is open to advanced medical equipment, offering ease of use and cost savings. Receptivity to used medical equipment is average. On one hand, there is a demand from end-users, but on the other hand, used equipment cannot be purchased through government tenders. However, private hospitals and clinics are in the market for used medical equipment.
Market Entry
U.S. companies entering the Ukrainian market should approach the market with a long-term perspective. Business in Ukraine is often based on relationships, so selecting a good local partner and/or establishing a local office are crucial to minimizing risk and facilitating long-term success. To find a potential partner, we recommend using the U.S. Commercial Service’s International Partner Search and/or Gold Key programs to conduct initial screening for prospective partners. (For more information please refer to https://www.trade.gov/ukraine.) U.S. companies should use appropriate due diligence in selection of partners and should be mindful of the parameters of the Foreign Corrupt Practices Act.
Kyiv is not the only trade hub in Ukraine. It is advised that U.S. companies look for distributors that have nationwide capabilities, including those located in the cities of Dnipro, Lviv, Odessa, Zaporizhzhya, and Kharkiv. These regions are considered important industrial centers in Ukraine and are densely populated. Covering the Ukrainian market from regional offices in Poland or Russia is not an effective approach. Ukrainian buyers are reluctant to go through regional offices, preferring to order direct from the manufacturer/wholesaler. Local presence is very important to successful business development in Ukraine.
Joining the American Chamber of Commerce and obtaining experienced legal and accounting support are other important considerations when contemplating doing business in Ukraine.
Current Market Trends
Public health priorities as announced by the government of Ukraine include; strengthening primary health care, optimizing the number and the structure of hospitals in Ukraine, responding to disease outbreaks, providing vaccinations, diagnosing health threats, providing water and food safety, and providing a safe living environment.
In this context, the Ministry of Health is highlighting 10 key healthcare reform priorities:
- New Financing System –guaranteed benefit package in 2018 includes primary care, palliative care, and urgent care,
- eHealth System – IT solution for ensuring that the government gathers accurate statistical information through patients’ and doctors’ registries,
- Hospital Districts – guaranteeing that the healthcare system is available for patients in every community,
- Quality of Care – the NHS will require doctors to meet international standards of treatment,
- Medical Education System – improving the quality of doctors within standardized examination programs and recognizing European medical licenses in Ukraine,
- Emergency Medical Care – settling the “Paramedic” educational program and special call centers, resolving the current high level of inappropriate use of the ambulance hotline,
- National Blood System – establishing the National Blood System for universal access to safe blood for Ukrainian citizens,
- Procurement – National Procurement Agency established in 2018 to involve more international and Ukrainian firms,
- Reference Pricing and Reimbursement – currently covering cardiovascular diseases, type II diabetes and asthma, with plans to expand this list,
- Public Health – establishing Public Health Centers for prevention of diseases and providing vaccinations and educational programs regarding diseases.
Market Size 2018
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Healthcare spending (including investment)
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U.S.D 8.6 bn
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… as percent of GDP
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Est. 7%
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… of which spent on inpatient services (including long-term care) [data n/a]
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|
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… of which spent on pharmaceuticals/consumables [data n/a]
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|
|
… of which spent on investments [data n/a]
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|
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… of which spent on outpatient services [data n/a]
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Hospitals, Procedures, Healthcare Professionals 2018
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Number of hospitals
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1,631
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…Public
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1,466
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…Private
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165
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Number of hospital beds
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293,446
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… available beds per capita (per 000 population)
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6.7
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…of which in general hospitals [data n/a]
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|
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…of which in specialized clinics and rehabilitation centers [data n/a]
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|
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Number of surgical procedures
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2,479.6
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…of which top procedure [data n/a]
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|
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…of which second highest [data n/a]
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|
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Physicians
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180,527
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Nurses
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257,549
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Dentists
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26,274
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Demographics
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Population (as of January 1, 2019)
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42.2 million
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Life expectancy men/women (2018)
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67.2/77.1
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Infant mortality (per 1,000 live births) (2018)
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7.0
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Percent of population older than 65 (est. 2018
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16.8
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…projection, 2030 [data n/a]
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|
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Annual deaths [per 1,000 population; 2018)
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14.8
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…caused by [cardiovascular diseases; data 2016]
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63%
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…caused by [cancer; data 2016]
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15.0%
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Source: World Health Organization, National Statistical Bodies, BMI
Main Competitors
In 2018, imports accounted for 90% of medical device sales in Ukraine. Major suppliers are China, the U.S., Germany, and Japan. The U.S. share was about 10% of total imports, and almost 25% in orthopedics and prosthetics imports.
Though Ukraine has a strong scientific research base, capable of developing highly advanced treatments and products, it lacks an accompanying strong manufacturing sector. Domestic manufacturers produce a range of equipment including respiratory anesthetic equipment, hearing aids, radiology, electrocardiography and ultrasound machinery, refrigeration and cryogenic equipment, specialized medical furniture, orthopedic appliances, surgery and dentistry tools, sterilizing equipment, electrodiagnostic equipment, and electrical stimulators. The range of domestically manufactured medical equipment remains limited, however, and the demand for expensive medical equipment is largely met by imports.
About 250 companies are developing and producing medical equipment in Ukraine. Domestic medical device production was worth about $103 million in 2018. Historically, exports tended to be largely at the lower end of the technology scale, but since 2017, diagnostic imaging exports account for nearly 40% of the total. Around 40% of exports are destined for former Soviet countries.
Registration Process
Ukraine is moving towards harmonization with European Union (EU) standards in the field of medical equipment/devices. In July 2015, a new national conformity assessment procedure governing the registration of medical devices was introduced. New products can enter the Ukrainian medical device market if they conform with technical regulations based on the EU Directives for medical devices. The new system introduces the following requirements for Ukrainian medical device registrations:
- Foreign registrants must appoint an Authorized Representatives based in Ukraine
- Expanded list of documentation and sample submissions required for registrations
- Manufacturing site inspections for Classes I, IIa, IIb, and III
- Special symbols of national conformity are required for medical devices imported into Ukraine
- National conformity certifications are valid for five years
Documentary expertise, on-site manufacturing inspections and testing of samples of medical devices is being performed by national authorized bodies (analogous to notified bodies in the EU). A list of state and private bodies that have been granted accreditation from the National Accreditation Administration of Ukraine and the Ministry of Economic Development and Trade can be found at
http://old.moz.gov.ua/docfiles/an_20150724_0_dod2.pdf (in Ukrainian)
Self-declaration is applied to:
- Class I medical devices, not sterile, without measuring functions (as defined by provisions in the technical regulation on medical devices (Decree of CMU №753);
- Analyzers, reagents, and other IVD products which are not included in lists “A” and “B” in the technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754).
Conformity assessment involving an authorized body is required for:
- Class I sterile medical devices, measuring medical devices, all medical devices of classes IIa, IIb, III according to provisions in the technical regulation on medical devices (Decree of CMU №753);
- In-vitro: self-testing devices; reagents, calibration, and control materials of lists “A” and “B” in the technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754);
- All active implantable medical devices according to the technical regulations on active implantable medical devices (Decree of CMU №754).
The conformity assessment procedure with the involvement of an authorized body may be conducted using one of the following routes:
- Assessment of the Quality Management System at the manufacturing site (on-site inspection), which results in issuing the conformity certificate for medical devices valid for 5 years related to the quality management certificate valid for 3 years.
- Conformity assessment of each batch, which involves issuing the certificate for the certain batch (shipment) of medical devices after documentary expertise and sample examinations.
Reimbursement
The program of state guaranties of medical treatment for the public is being introduced in Ukraine within the healthcare reform launched on July 1, 2018. The list and scope of healthcare services, devices and medicinal products to be financed from the state budget and provided to patients free of charge will be adopted annually as part of the state budget.
Barriers
Although the new Ukrainian registration system will bear many similarities to the CE Marking process for medical devices in Europe (https://www.emergobyul.com/services/europe/ce-certification), no simplified or expedited market pathways are available for devices already approved or cleared for sale in major markets such as Europe or the U.S. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities even if those sites are already ISO 13485-compliant.
According to current regulations, government tenders are to be non-discriminatory against foreign bidders.
Procurement & Tenders
Ukraine’s implementation of an e-procurement system in August 2016 presents opportunities for American companies to participate in Ukrainian public tenders. American suppliers interested in current public procurement opportunities in Ukraine may register for notifications at the Ukrainian Public Procurements Official National Web Portal PROZORRO: https://tender.me.gov.ua/EDZFrontOffice/.
FAQs
1. Is the CE mark enough to export a medical device to Ukraine?
No. To export a medical device to Ukraine, the device, bearing a CE mark, needs to receive a special symbol of national conformity. The conformity assessment procedure is conducted by an authorized body (see info above). Self-declaration is applied to Class I medical devices, not sterile.
2. What are the major sales channels in Ukraine?
There are two principal sales channels for medical devices served by diverse group of distributors, one for hospitals/clinics and one for pharmacies/orthopedic shops. The online sales channel for individual customers is developing.
U.S. Commercial Service Contact Information
Name: Olena Stephanska,
Position: Commercial Specialist
Email: olena.stephanska@trade.gov
Phone: +380 44 5215387
